1. Field of the Invention
The present invention relates to fiber optic delivery systems and laser medical systems, and to generating accurate information concerning use of such systems.
2. Description of Related Art
It is useful to gather accurate information about the operation of medical laser systems and for use of consumable delivery devices like optical fibers, for many purposes. For example, such information can be useful in analysis of the medical procedures followed using the systems, which is needed for research about improvements to the procedures. Also, such information can be used to prevent unsafe operation of the systems, including overuse of delivery devices that can degrade with excessive use, use of delivery devices that are not intended for use with the systems, and so on.
In the prior art, smart cards and like systems have been used to verify payment for operation of the systems, to ensure that the operators are authenticated before enabling use of the systems, to ensure that the host system is being used properly. For example, U.S. Pat. No. 6,536,431 describes a system for dispensing oxygen in which smart cards are used to ensure that the user has purchased credits that allow use. The smart card can also be used for “logging details such as parameters of each session of use of the dispenser,” (See, '431 patent, column 5, lines 6-17) so that the nature of use of the dispenser can be monitored over time. The logging information relates only to use of the dispenser, and the person possessing the card. U.S. Pat. No. 6,298,255 describes a “smart sensor” which includes a memory module used as a data archive for “patient and performance data.” (See, '255 patent, column 6, lines 3-10). U.S. Pat. No. 6,149,643 describes a system in which a smart card is used for pre-payment for use of a laser system for vision correction. According to the '643 patent, data from procedures can be transferred to the smart card for storage (See, '643 patent, column 3, lines 55-58; and column 21, lines 10-41).
The prior art smart cards just described are not used to log information about use of a delivery device adapted for a specific laser system, sold separately from the laser system, nor verify use of a proper delivery device. Thus, such prior art systems are not suitable for ensuring use of authorized delivery devices, for ensuring safe use of delivery devices, or for gathering data about use of such devices.
In one prior art, a laser system includes a smart card reader, and software that relies on the smart card for the purposes verifying use of a correct type of delivery device, and preventing overuse of such device. In this prior art system, a “smart card” is provided in a kit including a fiber optic delivery device. The smart card is arranged to allow use of the delivery device for a single procedure. The fiber optic delivery device includes a device ID indicating the type of delivery device is read by the laser system software. The laser system software requires that a device type ID stored on the smart card in the kit, matches the device type ID of the attached delivery device and that the card is valid before allowing the system to enter an application mode.
In operation, the prior art system executes a mutual authentication protocol when the smart card is inserted into the card reader on the laser system, to determine if the laser and card are both genuine. Once the card and laser have been authenticated, memory in an unused card is stamped with the identifying data. If the card is used, when it is inserted as indicated by identifying data stored on the card, the data indicating an amount of energy use on the card is checked to insure that the prior use did not result in delivery of energy sufficient for a full procedure. This prevents unsafe reuse, while enabling insertion and removal of the card during set up or for arbitrary reasons. If the device associated with the card has been used for a procedure, the card will no longer be valid and a message will appear on the laser system indicating that the card has expired. Also, the card is invalidated and the laser system is disabled.
This process is repeated whenever the card is removed and reinserted, the fiber optic delivery device is removed and reattached, or the power is turned off and back on. Thus, the prior art system is used to ensure that an authentic kit us being used, that the proper type of delivery device is attached, and that the delivery device is not being used for more than one procedure.
U.S. Pat. No. 5,742,718 describes a fiber optic delivery device with a smart card attached to it. The '718 patent mentions that the card can be used for storing data about use of the device during procedures (See, '718 patent, column 7, lines 24-50, column 8, lines 19-60). However, there are no safeguards provided against circumvention of the data logging function in the card, so that the delivery device could be used “off record”, and making the data gathering process unreliable. In order for data logging to be useful in detailed analysis, it is necessary that complete data be gathered. Without safeguards against operating the laser system and using the delivery device off record, then the prior art approaches are not satisfactory for use in important analysis and record keeping.
It is desirable to provide a system and method that improves the data gathering processes associated with laser systems and delivery devices used in medical procedures.